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Recruiting NCT07114718

Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study

No phase Interventional Congenital Heart Disease Congenital Heart Disease (CHD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ductus Arteriosus Stent.
Who it may be relevant to
Registry conditions: Congenital Heart Disease, Congenital Heart Disease (CHD). Basic parameters: 1 Minute — 6 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Starlight Cardiovascular, Inc. is sponsoring a prospective, multi-center, study to evaluate safety and effectiveness of the Lifeline Ductus Arteriosus Stent System. The study device is a stent that is designed to maintain patency of the Ductus Arteriosus for children who need blood flow through that part of the heart.

Detailed description

Starlight Cardiovascular, Inc. is sponsoring a prospective, multi-center, study to evaluate safety and effectiveness of the LifelineTM Ductus Arteriosus Stent System.

The purpose of the study is to determine whether the Ductus Arteriosus Stent System demonstrates safety and effectiveness for patients who require ductal patency and merits Food and Drug Administration (FDA) approval.

Interventions

  • Device Ductus Arteriosus Stent
    The eligible subjects will proceed to implantation of the Lifeline Ductus Arteriosus Stent to maintain patency of the PDA.

Primary outcome measures

  • Primary Safety Endpoint [Time frame: Implant to 30 days]
  • Primary Efficacy Endpoint [Time frame: Implant to 180 days]

Eligibility criteria

Inclusion criteria

  • Parental or legal authorized representative provide consent for study enrollment
  • Infants < 6 months of age
  • Diagnosis of congenital heart defect with ductal-dependent pulmonary circulation requiring infusion of prostaglandins
  • Requires ductus arteriosus stent diameters of 3.5mm or 4mm and stent lengths between 16mm and 28mm

Exclusion criteria

  • Active blood stream infection
  • Active or history of endocarditis
  • Body weight <2.5kg
  • Gestational age <32 weeks at birth
  • Complete heart block
  • Total Anomalous Pulmonary Venous Return
  • Anatomic variation judged to be inappropriate for ductal stenting per the treating interventionalist
  • Presence of an aortopulmonary collateral that is expected to require unifocalization
  • Non-confluent pulmonary arteries (i.e. isolated pulmonary artery of ductal origin) or bilateral patent ductus arteriosus (PDA)
  • Pulmonary atresia with intact ventricular septum with RV-dependent coronary circulation
  • Currently participating in an investigational drug study or another device study that would confound the study results
  • Patient who is on extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), or dialysis prior to ductal stenting procedure
  • Major co-morbidities which, in the opinion of the investigator, would negatively alter expected 1-year survival (e.g., intracranial hemorrhage, renal failure, etc.)
  • Patient who is undergoing another transcatheter procedure (e.g., atrial septostomy, aortic arch intervention, or right ventricular outflow tract intervention) during or within 24 hours prior to the ductus arteriosus stenting procedure
  • Patient who, at the time of enrollment, is deemed not to be a candidate for eventual stage II palliation of single ventricle heart disease, complete surgical repair, nor transcatheter treatment with resultant biventricular circulation
  • Patient who does not plan to return to the enrolling center or another participating center for stage II palliation, complete surgical repair, or definitive catheterization procedure
  • Contraindications to peri-procedural anticoagulation
  • Known to be non-responsive to aspirin or other antiplatelet therapies
  • Known hypersensitivity or allergy to Nickel
  • Known hypersensitivity to contrast media that cannot be adequately pre-medicated

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 8 centers
  • UCLA Mattel Children's — Los Angeles
  • Leland Stanford Junior University — Stanford
  • Children's Hospital Colorado — Aurora
  • Boston Children's Hospital — Boston
  • Cincinnati Children's Hospital Medical Center — Cincinnati
  • Nationwide Children's Hospital — Columbus
  • Texas Children's Hospital - Baylor College of Medicine — Houston
  • Seattle Children's Hospital — Seattle

Identifiers

NCT: NCT07114718 · G250132 · 2R44HL158304-04A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗